International Electrical Storm Registry

Arrhythmias, Cardiac Clinical Trial

— ELECTRA  

Official title:

Multicenter Registry on Patients Affected by Electrical Storm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02882139
• Other study ID #: 2016-0364 OR
• Status: Recruiting
• Start date: August 2016
• Est. completion date: August 2021

Study information

• Verified date: October 2018
• Source: Università Politecnica delle Marche
• Contact: Federico Guerra, M.D.
• Phone: +390715966593
• Email: f.guerra[@]univpm.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Organized ventricular arrhythmias (ventricular tachycardia (VT), torsades de pointes (TdP) and ventricular fibrillation (VF)) represent a major event in the clinical history of a patient and they can lead to hemodynamic instability and sudden cardiac death (SCD). Recurrences of ventricular arrhythmias and electrical instability have exponentially increased in the last decades and a new clinical entity called "electrical storm" (ES) has emerged as major morbidity and mortality factor. The ES is defined as a cluster of 3 or more sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia lasting 12 hours or more and that does not respond to treatments.

Most of the patients presenting ES are already implanted with an ICD. This is due to 3 factors: first, patients with ICD implant are at higher risk to develop ventricular arrhythmias for the cardiac disease that led to the ICD implant. Second, the device records and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would not be detected. Third, and more important, the device gives the possibility to survive to an arrhythmic episode, making it possible for the patient to experience an ES. The incidence of ES is debated in different studies and ranges from 10 to 60% in patients with ICD for secondary prevention and from 4 to 7% in patients with ICD for primary prevention.

The aim of the ELECTRA registry is twofold:

1. To create an international registry on clinical features, optimal therapy, ablation strategy, prognosis and the effect of ICD programming on patients with ES.

2. To use the data derived from the registry for a prospective, observational study on mortality and rehospitalization rate in patients with ES.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2021
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Diagnosis of ES (documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h).In order to fulfill this criterion, a patient with a previous episode of ES could also be enrolled during routine screening.

• Age =18

• Written informed consent

Exclusion Criteria:

• patient without ICD

• Confirmed or suspected use of drugs or narcotics with known direct pro-arrhythmic effect

• Inability to express an informed consent for the study

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Defibrillators, Implantable
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation

Locations

Country	Name	City	State
Italy	Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital "Ospedali Riuniti"	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Guerra F, Bonelli P, Flori M, Cipolletta L, Carbucicchio C, Izquierdo M, Kozluk E, Shivkumar K, Vaseghi M, Patani F, Cupido C, Pala S, Ruiz-Granell R, Ferrero A, Tondo C, Capucci A. Temporal Trends and Temperature-Related Incidence of Electrical Storm: Th — View Citation

Guerra F, Flori M, Bonelli P, Patani F, Capucci A. Electrical storm and heart failure worsening in implantable cardiac defibrillator patients. Europace. 2015 Feb;17(2):247-54. doi: 10.1093/europace/euu298. Epub 2014 Oct 26. — View Citation

Guerra F, Palmisano P, Dell'Era G, Ziacchi M, Ammendola E, Bonelli P, Patani F, Cupido C, Devecchi C, Accogli M, Occhetta E, Santangelo L, Biffi M, Boriani G, Capucci A; Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Implantable cardiover — View Citation

Guerra F, Palmisano P, Dell'Era G, Ziacchi M, Ammendola E, Pongetti G, Bonelli P, Patani F, Devecchi C, Accogli M, Occhetta E, Nigro G, Biffi M, Boriani G, Capucci A; Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Cardiac resynchronizatio — View Citation

Guerra F, Shkoza M, Scappini L, Flori M, Capucci A. Role of electrical storm as a mortality and morbidity risk factor and its clinical predictors: a meta-analysis. Europace. 2014 Mar;16(3):347-53. doi: 10.1093/europace/eut304. Epub 2013 Oct 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		Three years
Secondary	Hospitalization for all causes		Three years